Guidelines for collaboration with industry should be transparentBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f6100 (Published 09 October 2013) Cite this as: BMJ 2013;347:f6100
- Ben Goldacre, Wellcome Research Fellow in Epidemiology, London School of Hygiene and Tropical Medicine,
- David Carroll, medical student, Queens University Belfast,
- Elizabeth Hall, foundation year 1 doctor, St Thomas’ Hospital, London
This week a secretive organisation representing almost all doctors in the UK seems to have disbanded, but even this much is hard to know. The Ethical Standards in Health and Life Sciences Group (ESHLSG)1 included most major medical professional bodies in the UK, co-chaired by the Association of the British Pharmaceutical Industries (ABPI) and the Royal College of Physicians. It produced two documents, on collaboration with the drug industry2 and clinical trial transparency,3 both of which were endorsed and co-badged by almost all leading medical organisations, Royal Colleges, faculties, and societies.
The ESHLSG’s positive claims about the benefits of industry sponsored education, and of seeing drug company sales representatives, were criticised almost immediately for going against the best available evidence on the impact of industry promotional activity.4 5 But much more worryingly, the ESHLSG documents make a series of factually incorrect claims about transparency and clinical trials, giving false reassurance on one of the biggest challenges for evidence based medicine today: the routine withholding of clinical trial results from doctors, researchers, and patients (www.alltrials.net).
The ESHLSG “guidance” document, for example, claims that “information about industry trials is made publicly available.” This statement is untrue: the best current evidence on publication bias comes from a 2010 review, which estimates that only around half of all clinical trials go on to be published.6 Research from this year confirms that finding,7 and it is clear that even limited US legislation has been ignored.8 The ESHLSG makes no mention of this evidence, nor any other evidence on the prevalence of publication bias, in any document.
The companion “transparency” document from the ESHLSG gives even more direct false reassurance. Firstly, it claims that there is “a robust regulatory framework governing disclosure of clinical trial information.” No such regulatory framework exists, and there is no legislation that gets access to the results of all trials on all medicines currently in use for doctors, patients, participants, researchers, or payers.
Next, the ESHLSG states that its work is based on “The fact it is impossible to get new medicines approved or data published in the top medical journals without prospective disclosure of clinical trial information on approved registries.” This, again, is simply untrue. One study found that only half of all trials published in high impact journals were adequately registered, and a quarter weren’t registered at all.9 Several further studies, both before and since, have reached similar findings.
In response to the ESHLSG giving false reassurance on these issues we founded the Bad Guidelines campaign with colleagues (badguidelines.org). The Lancet withdrew its support for the ESHLSG immediately.10 In March, the British Medical Association also withdrew its support, and resigned its membership of the group.11 To date, no other signatories have taken action.
Since all signatories are large organisations, with professional policy departments—which are often cautious about endorsing specific campaigns—we contacted them to ask how they came to endorse these false claims. Almost all have refused to answer. None has given a clear account.
The ESHLSG itself is even less transparent. From the outset there were no publicly accessible minutes, and our request for retrospective minutes was rejected. There was no list of representatives from signatory bodies, no declaration of conflicts of interest for those members, and no information about the group’s funding. Skeletal versions of this information were finally provided over the past few months, but this has all now been suddenly deleted, along with the formal ESHLSG documents themselves, replaced by a single holding page. There has been no explanation beyond a brief earlier statement in February that the content was being “reviewed.” A BMJ journalist has apparently been told the group is “disbanding.”12 No outcome of the “review” has been given.
This is very peculiar. If the ESHLSG has now retracted these documents—if it or its signatory members now recognise that their formal output contains a series of factually incorrect statements, giving false reassurance on important matters of public health—then it should say so, clearly and publicly, because these documents have created genuine harm. Campaigns such as AllTrials have worked successfully over the past year to help stop clinical trial results being withheld from doctors and patients, but they have done so against a culture of denial.
The best we can hope for is that the false claims in the ESHLSG documents reflect the industry running rings around their academic and medical collaborators. This is a shame. Clear guidelines on working with industry would still be useful, if based on real evidence, as collaborative work between industry and medics can be extremely positive—but not when it requires us to say things that are not true. This, ironically, was the very problem that the ESHLSG set out to address.
Cite this as: BMJ 2013;347:f6100
Competing interests: BG receives income from writing and speaking on problems in science and medicine, including publication bias and the influence of industry. DC and EH are on the national committee of PharmAware, an organisation of medical students affiliated with Medsin-UK. DC and EH are members of Health Action International Europe. EH is on the management committee of Healthy Skepticism-UK. All authors are involved in the Bad Guidelines campaign.
Provenance and peer review: Commissioned; not externally peer reviewed.